Continuous glucose monitoring injection device

ABSTRACT

An electronic insulin delivery device receives glucose data from a glucose monitor and sets a bolus dose amount. The device may take the form of an insulin pen with automatic priming and accurate dosing provided by a motor in connection with an encoder. The device may communicate with and be controlled by a smart phone device. The smart phone device provides a user interface to receive user data including patient weight, insulin to carbohydrate ratio and exercise factor, and to send instructions to the device, including dose amount. The dose amount is determined taking into account glucose level and trend, and other factors. The delivery device may be in continuous communication with the glucose monitor and smart phone to provide for near real-time adjustments in glucose treatment. Glucose data, insulin injection data, and other relevant data may be stored and accessible to interested parties.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates generally to an intelligent injectiondevice. More specifically, the present invention relates to an insulininjector with intelligence and communication capabilities that iscapable of providing optimized bolus doses of insulin based oninformation received from a glucose sensor. Embodiments also relate toinjectors that communicate data within a health system to provideinformation to interested parties including the patient and theirhealthcare provider.

Description of the Related Art

Diabetes is a group of diseases marked by high levels of blood glucoseresulting from defects in insulin production, insulin action, or both.Diabetes can lead to serious complications and premature death, butthere are well-known products available for patients with diabetes tohelp control the disease and lower the risk of complications.

Treatment options for diabetics include specialized diets, oralmedications and/or insulin therapy. The primary goal for diabetestreatment is to control a diabetic's blood glucose level in order toincrease the chances of a complication-free life. Because of the natureof diabetes and its short-term and long-term complications, it isimportant that diabetics have a constant awareness of the level ofglucose in their blood. For patients who take insulin therapy, it isimportant to administer insulin in a manner that maintains glucoselevel, and accommodates the tendency of glucose concentration in theblood to fluctuate as a result of meals and other activities.

Diabetics' bodies have difficulty regulating the production of insulinto manage glucose concentration in their blood. Accordingly, a primarygoal of insulin therapy is to help the patient maintain a healthyglucose concentration. Two main components of insulin therapy aremeasuring glucose level, and delivering insulin as needed. Somediabetics use finger sticks to draw blood samples and test for glucoselevel, and multiple daily injections (MDI) of insulin. This type oftherapy is relatively simple, but requires multiple daily finger sticksand needle injections, which are inconvenient and painful. In addition,the control of glucose is relatively crude, since glucose is measuredonly episodically, and insulin is delivered episodically with eachinjection.

Insulin pens typically provide the ability to set a dose. Accordingly, apatient can determine how much insulin they need and set the appropriatedose, and then use the pen device to deliver that dose. This system,however, requires a higher level of sophistication and involvement onthe part of the patient.

At a more sophisticated level, other diabetics use insulin pumps todeliver a basal rate of insulin continuously. Insulin pumps may alsoprovide bolus doses of insulin as needed. Insulin pumps are animprovement because they deliver insulin continuously, rather thanepisodically. They typically include a refillable or replaceable insulinreservoir. They also avoid most of the needle sticks associated withMDI. However, pumps have disadvantages because they can be inconvenientfor the user to wear, and require tubing connected to an insertion setat the injection site. They are also expensive since they requireelectronics and an accurate pump mechanism.

Patch pumps are an insulin delivery device that generally falls betweenMDI and sophisticated insulin pumps. Patch pumps are typicallydisposable devices that stick to the patient's skin, and include aninsulin reservoir, and a cannula insertion mechanism. Patch pumps mayhave, but do not require, electronics. They typically include areservoir of insulin containing a three day supply of insulin fordelivery to the patient. Patch pumps may provide a basal rate ofinsulin, either electronically or mechanically metered, and may alsooptionally provide bolus doses. There are some patch pumps that deliveronly bolus doses. Patch pumps are typically disposable after theirroughly three days of use, but some patch pumps may include both durableand disposable components.

There are typically two methods for measuring a user's blood glucoselevel. One method uses an electronic blood glucose meter wherein asample of blood is obtained by piercing the skin of a user with alancet. The sample of blood is then placed on a chemically-activetest-strip, which interfaces with the blood glucose meter. Withinseveral seconds of inserting the test-strip into the blood glucosemeter, the blood glucose level of the user is read and shown on thedigital display of the blood glucose meter.

The blood glucose meter method provides an accurate snapshot of a user'sblood glucose level at a single moment in time. However, the bloodglucose meter method does not indicate whether the user's glucose levelis rising, falling, or steady. Additionally, the blood glucose metermethod fails to capture a user's changing blood sugar levels aftermeals, between meals, and during the night.

Insulin delivery devices and glucose sensors may be combined to providebetter therapy. An idealized “artificial pancreas” system wouldcontinuously measure glucose levels, and continuously communicate withan insulin delivery device to continuously deliver appropriate amountsof insulin through feedback and determinations. Such a system would alsopreferably capture glucose measurement and insulin delivery data andprovide such information to the patient and their healthcare provider.However, the “artificial pancreas” concept requires expensive equipment,and requires the user to wear an insulin pump with an insertion set andrelated tubing, which many find inconvenient. While daily injections ofinsulin are effective for many, daily injections could be improved withadjustable dosing and dosing based on real time or near real time data.However, the currently exist no systems in which there is an interactionbetween monitored glucose levels, injections of insulin, and therecording of daily events.

SUMMARY OF THE INVENTION

Exemplary embodiments of the present invention address some or all ofthe above problems and/or disadvantages and provide at least theadvantages described below.

According to one embodiment of the present invention, an electronicinsulin delivery device for administering a bolus of insulin to apatient is provided. The electronic insulin delivery device includes areceiver configured to receive patient glucose information from anelectronic glucose monitor, a processor configured to read the receivedpatient glucose information and determine an appropriate insulin bolusdose for the patient, a dose setting mechanism configured to set aninsulin delivery amount corresponding to the determined insulin bolusdose, and a housing having at least one user interface buttoncorresponding to a dispense function for dispensing the determinedinsulin bolus dose.

According to another embodiment of the present invention, a method in anelectronic insulin delivery device for administering insulin to apatient is provided. The method includes receiving glucose informationfrom a glucose monitor, receiving additional patient information from anelectronic device via a wireless communication interface, setting aninsulin bolus dosage amount based on the glucose information and theadditional patient information, and activating a user interface on theelectronic insulin delivery device to display the insulin bolus dosageamount.

According to another embodiment of the present invention, an electronicinsulin delivery device for administering a bolus of insulin to apatient is provided. The electronic insulin delivery device includes areceiver wirelessly configured to wirelessly connect to an electronicglucose monitor and an electronic device, the receiver configured toreceive patient glucose information from the electronic glucose monitorand additional patient information from the electronic device. Thedelivery device further includes a processor configured to read thereceived patient glucose information and the additional patientinformation, determine a patient status based on the received patientglucose information and additional patient information, determine if anotification should be actuated, and actuate a notification.

BRIEF DESCRIPTION OF THE DRAWINGS

The various objects, advantages and novel features of the exemplaryembodiments of the present invention will be more readily appreciatedfrom the following detailed description when read in conjunction withthe appended drawings, in which:

FIG. 1A is a system diagram of an example of a system for deliveringmedicament to a patient.

FIG. 1B is a system diagram of a system for delivering medicament to apatient in accordance with an illustrative embodiment.

FIG. 1C is a system diagram of a system for delivering medicament to apatient in accordance with an illustrative embodiment.

FIG. 2 illustrates components of a wireless system according to anembodiment of the present invention;

FIGS. 2A and 2B illustrate screenshots of an exemplary embodiment of theinvention;

FIG. 2C illustrates additional screenshots of an exemplary embodiment ofthe invention;

FIG. 3 is a block diagram of a smart bolus injector according to anexemplary embodiment of the invention;

FIG. 3A is an isometric view of the smart bolus injector of FIG. 3;

FIG. 3B is a section view of the smart bolus injector of FIG. 3;

FIG. 3C is a top exploded view of the smart bolus injector of FIG. 3;

FIG. 3D is a bottom exploded view of the smart bolus injector of FIG. 3;

FIG. 3E is the flow diagram of user interface screens of the smart bolusinjector of FIG. 3 with each box representing a separate screen on thedevice.

FIG. 4 illustrates a system including a health management access pointaccording to another exemplary embodiment of the invention;

FIG. 5 illustrates an integrated smart pen and BGM device according toan exemplary embodiment of the invention;

FIG. 6 illustrates a system including a health management access pointaccording to another exemplary embodiment of the invention; and

FIG. 7 illustrates a system including a health management access pointaccording to another exemplary embodiment of the invention.

Throughout the drawing figures, like reference numbers will beunderstood to refer to like elements, features and structures.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Exemplary embodiments of the invention will now be described inconnection with the attached drawing figures. One exemplary embodimentof the invention is a smart bolus delivery system, for example, used asan insulin delivery device. The smart bolus delivery system may beintegrated with a glucose sensor, a controller, a fitness tracker, and acloud-based platform to improve therapy and provide data management. Itshould be understood that the following examples are described inconnection with diabetes case, but the invention is not limited todiabetes care. For diabetes care, an exemplary system combines theaccuracy and smart functions of an ambulatory insulin pump with theconvenience and simplicity of a smart insulin pen to provide a ‘near’closed loop control of insulin or other medicament that may have aregulating effect on the disease to improve patient medication adherenceand treatment outcome. The exemplary medicament delivery system providesbasic injection needs, that is, safety combined with complex dosedeterminations, and interaction means between patients, healthcareproviders and payers. To achieve a ‘near’ closed loop control, aninsulin delivery device can be configured to connect and communicatewith one or more external devices that receive or monitor informationaffecting insulin dosage or that determine insulin dosage requirements.

In one embodiment, the insulin delivery device can process data from theexternal devices to determine a current status of a user. The insulindevice may notify a user of various conditions or events in response tothe determined status. In some embodiments the insulin device may be incontinuous or near-continuous communication with one or more of theexternal devices. In other embodiments, the insulin device maycommunicate with, or receive data from, one or more external devicesregularly, semi-regularly, or intermittently. As used herein, the term“regularly” means on a predetermined schedule. For example, the insulindevice may receive data from other devices every 0.5, 1, 2, 5, 10, 15 or30 minutes in some embodiments. The insulin device may be connected toone or more external devices using wireless protocols such as WiFi andBluetooth. The insulin device can also continuously or near-continuouslyprocess data received from one or more external devices to determine astatus of the user and notify the user to various conditions or events.In some embodiments, data is processed regularly, semi-regularly, orintermittently. Frequent communication of data between the externaldevices and the insulin device and the processing of data based oncurrent information and historical information can allow for usernotification and changes in insulin dosage based on real-time or nearreal-time activity and meal composition data.

FIGS. 1A and 1B illustrate an artificial pancreas system, and how asmart bolus injector in the form of an electronic insulin deliverydevice or intelligent insulin pen can replace a conventional insulinpump in such a system to provide benefits which will be described below.The artificial pancreas system 100 is utilized by a patient 102, andincludes a blood glucose monitoring (BGM) device 104, a continuousglucose monitor (CGM) 106, and a computing device 108 to execute one ormore processes. The computing device 108 is illustrated as a standalonepersonal computer. However, it should be understood that any suitabledevice capable of executing the requisite processes, receiving therequisite inputs, and transmitting control signals and data to necessarydevices will suffice. In particular, smart phones may perform thefunction of the computing device 108 in this system.

In the artificial pancreas system, the CGM provides continuous bloodglucose concentration measurement data to the computing device 108. TheBGM device is preferably used to calibrate the CGM 106 device. In FIG.1A, an insulin pump 110 transmits insulin infusion data to the computingdevice 108. The computing device 108 executes a process that preferablyaccounts for CGM concentration and trend data received from the CGM 106,insulin infusion data received from the insulin pump 110, and any otherrelevant data, including food intake data, and computes adjustments tothe insulin infusion rate necessary to optimize healthy glucose levelsin the patient. The infusion rate adjustments are transmitted to theinsulin pump 110 and implemented by the insulin pump 110.

In one exemplary embodiment as depicted in FIG. 1B, the insulin pump 110is replaced by a smart bolus injector 112. The smart bolus injector 112may be in the form of an electronic insulin pen with additionalfeatures. First, the smart bolus injector 112 is capable of receiving aninstruction from the computing device 108 in order to set a dose amount.Second, the smart bolus injector 112 is capable of automatically primingthe injector and delivering a bolus dose corresponding to theinstruction received from the computing device. It should be understoodthat the computing device 108 may be a separate component, such as apersonal computer or smart phone, but the computing device may also beincorporated into the smart bolus injector 112. The smart bolus injector112 can include components to receive data from external devices, suchas the CGM 106 and the computing device 108.

In accordance with an illustrative embodiment, the smart bolus injector112 is in continuous, near continuous, or regular communication with theCGM 106, and may be in continuous, or nearly continuous, communicationwith the computing device 108 and the BGM device 104. In someembodiments, the smart bolus injector 112 can communicate with otherexternal devices that measure or receive dosage relevant information,such as physical activity information, sleep information, dietinformation, weight information, and other useful information. In someembodiments, the dosage relevant information can be entered directlyinto the computing device 108. In some embodiments, the dosage relevantinformation can be received from one or more monitoring devices, suchas, for example, a physical activity monitoring device, a sleepmonitoring device, a diet monitoring device, and a scale. In someembodiments, one or more of physical activity information and sleepinformation are monitored by a wearable device. A physical activitymonitor can measure data including distance traveled, distance climbed,calories expended, and duration of time at a particular activity level.A sleep monitor can measure data including sleep efficiency, sleepmovement, and number of interruptions during a sleep cycle.

The smart bolus injector 112, in some embodiments, may incorporate ablood glucose monitor, but preferably also includes components toreceive external data. For example, a user interface can be provided inthe smart bolus injector 112 allowing for input of data from a user. Thesmart bolus injector 112 can also include components to continuously, ornear continuously, receive data from and communicate data to a separatedevice over a network, such as from cloud storage for example. The smartbolus injector can also include components to receive data from andcommunicate data to a separate device through a wired connection.Advantageously, such an exemplary system provides most of the advantagesof a full artificial pancreas system, without the user inconvenience ofwearing an insulin pump and insertion set.

Another exemplary embodiment is described below in connection with FIG.1C. This system 200 includes a smart insulin pen 202 that is preferablyequipped with a user interface such as the one illustrated in FIG. 3E, aBGM 204 or a CGM 206, a computing device 208 and a health managementaccess point 210. In some embodiments, a BGM 204 is used, while in somealternative embodiments, a CGM 206 is used to more closely achieve thecapabilities of an artificial pancreas system. In either case, theinsulin pen 202 is equipped with a communication interface, preferably awireless communication interface. The insulin pen 202 continuously, ornear continuously, receives data from the BGM 204 or CGM 206 via thecommunication interface. The insulin pen 202 also receives data from thecomputing device 208. In some embodiments, the insulin pen 202 receivesdata from one or more other external devices that measure dosagerelevant information, such as a physical activity monitoring device, asleep monitoring device, a diet monitoring device, and a scale. The datareceived from the computing device may be used with a process fordetermining an insulin dose based on glucose concentration data receivedfrom the BGM 204 or CGM 206, as well as any other relevant data.

The computing device may transfer instructions to execute a process tothe insulin pen 202 for execution in the insulin pen 202. Alternatively,the process may be executed on the computing device 208 and the requireddose information can be transferred to the insulin pen 202. The insulinpen 202 includes a controller that controls a dose setting mechanismwithin the insulin pen 202. The controller receives dose informationdetermined with a patient specific process and sets the doseaccordingly. Advantageously, the process may be adjusted or updated by athird party, such as a healthcare provider, via the health managementaccess point 210. As illustrated, the health management access point 210includes a bi-directional communication interface. In this manner,healthcare providers can access patient information including up to daterecords related to the patient's glucose concentration records, insulininjection records, and a current patient specific process. Thehealthcare provider can similarly send adjustments to the patientspecific process to modify the insulin regimen to better controlglucose. The patient specific process may be updated by the healthcareprovider sending an updated patient specific process to the computingdevice 208 from the health management access point 210. The insulin pen202 and/or the computing device 208 may send data to the healthmanagement access point 210 that includes time stamped blood glucoseconcentration records from the BGM 204 or CGM 206, insulin injectiondata from the insulin pen 202, and any other relevant data captured bythe system 200. In one embodiment, the insulin pen 202 and/or thecomputing device 208 are in continuous, near continuous, or regularcommunication with the health management access point 210. In oneembodiment, the insulin pen 202 makes use of a user interface asillustrated in FIG. 3E and retrieves the patient specific process fromthe computing device 208, and then determines a required dose based onavailable data. The controller then sets the required doseautomatically. The insulin pen preferably includes audible, tactile, orother means to notify the patient of successful or unsuccessfulinjections, and records the results for future use in the process. Theinsulin pen preferably transfers injection data to the health managementaccess point 210. The insulin pen also preferably incorporates certainfeatures of a bolus injector, including delivering real-time glucoseinformation, alerting to high or low glucose readings or failedinjections, and providing glucose trend information such that patientsmay advantageously make more informed decisions to better control theirdisease.

FIG. 2 illustrates another system according to an embodiment of thepresent invention. The system 250 includes a smart phone 252, a CGM 254and a smart pen injection device 256. The injection device 256communicates wirelessly with the CGM 254 and/or the smart phone 252. Thewireless connections may utilize any suitable wireless protocolincluding without limitation IEEE 802.11 WiFi, Bluetooth or Zigbee. Theinjection device 256 may include an encoder and mechanical drive poweredby a 12 mm gear motor to drive the plunger in a controlled fashion todeliver accurate doses of insulin. Flow precision is improved by the useof encoders to drive the plunger in a controlled fashion. In oneembodiment, the mechanical drive is capable of delivering 30 units ofinsulin in 5 seconds, and can generate at least 80 psi pressure in theinsulin cartridge, and utilizing a 100:1 gear ratio, 120 psi can beachieved. As discussed above, system 250 includes wireless connectivitybetween the smart pen injection device 256 and the CGM 254 and the smartphone 252. In some embodiments, one or more of the injection device 256and the smartphone 252 can connect to and communicate with otherexternal devices that measure or receive dosage relevant information,such as physical activity information, sleep information, dietinformation, weight information, and other medicine used information. Insome embodiments, the dosage relevant information can be input into thesmartphone 252. In some embodiments, the dosage relevant information canbe received from one or more monitoring devices such as for example, aphysical activity monitoring device, a sleep monitoring device, a dietmonitoring device, and a scale. The injection device 256 may regularlycommunicate with one or more of the CGM 254, the smart phone 252, andthe other external devices. The injection device can also be incontinuous, near continuous, intermittent, or semi-regular datacommunication with one or more of the CGM 254, the smart phone 252, andthe other external devices. The system 250 also preferably includes asecured data recording and managing system that is accessible to thepatient, authorized healthcare managers and payers or insurers. Thesystem 250 also may include a BGM device 258 that is wirelesslyconnected to the smart phone 252. The BGM 258 may alternately beembedded and hardwired into the injection device 256. In someembodiments, the smart phone 252 can determine insulin doserequirements, both basal and bolus, based on the patient's physiologicalinformation, including glucose concentration measurements and history.The injection device 256 can also include computing capabilities fordetermining insulin dose requirements. The injection device 256 performspriming and bolus injection, based on a dose amount determined andtransmitted to a controller in the smart pen injection device 256. Oneor more of the smart phone 252 and the injection device 256 can alsoperform data recording of glucose monitoring data received from the CGM254, and insulin injections performed by the injection device 256. Insome embodiments, the injection device 256 can include a memory forstoring data.

In some embodiments, the injection device 256 can process data receivedfrom one or more of the CGM 254, the smart phone 252 and the otherexternal devices to determine a status of a user. For example, theinjection device 256 can determine high or low glucose readings, therequirement of an insulin dose, an insulin dosage amount, or therequirement of emergency medical treatment. Determinations may be basedon both current and historical trend data. The injection device 256 mayprocess data regularly, semi-regularly, continuously, near continuously,or intermittently. In some embodiments, data is processed in real-timeor near real-time. The injection device 256 can also notify a user ofvarious conditions and events in response to the status determinations.The injection device 256 may be configured to provide tactile, visual,or auditory notifications to the user. For example, the injection device256 may display a notification on a user interface of the injectiondevice 256. The user interface may display a current glucose level, anotification that the glucose level is high or low, a notification thatan insulin injection is required, or a notification that emergencymedical assistance is required. In some embodiments, the injectiondevice 256 may vibrate to alert a user to a notification. In someembodiments, the injection device 256 may produce an auditorytransmission, such as a chirp, beep, or ringtone, to alert a user to anotification. Notifications may also be transmitted to external devices,such as the smartphone 252, and to medical personnel for data trackingor emergency services.

FIG. 2A illustrates an exemplary screenshot 260 of a smart phoneapplication running on a smart phone, such as smartphone 252, inaccordance with an exemplary embodiment of the invention. Screenshot 260depicts user inputs for body weight 262, insulin-to-carbohydrate ratio264, sensitivity factor 266, exercise factor 268, and target bloodglucose 270. The inputs can be entered using a user interface on thesmart phone 252. In some embodiments, one or more of the inputs may bereceived from an external device. For example, body weight 262 may bereceived from a scale or weight monitoring application. The exercisefactor 268 may be based on exercise data received from an activitymonitoring device or application. The insulin-to-carbohydrate ratio maybe based on data received from a diet monitoring device or application.The sensitivity factor may be based on data received from one or more ofa continuous glucose monitor, a blood glucose monitor, and a smartinjection device. The smart phone application may also receive data froma sleep monitoring device or application. The smart phone may alsoreceive data related to other medicine used by the patient. The smartphone application preferably determines the total daily insulin andbasal dose 274 based on the patient's weight. A bolus dose is estimatedusing the insulin-to-carbohydrate ratio 264, the sensitivity factor 266,and the exercise factor 268. In one exemplary process, the followingdeterminations are made. First, total daily insulin (TDI), in units, isdetermined as body weight in pounds divided by four (4). A basal dose isset at 40-50% of the TDI. Overnight insulin preferably remains constant.A bolus dose is set at 50-60% of the TDI, taking insulin-to-carbohydrateratio 264, sensitivity factor 266 and exercise factor 268 into account.The application assumes that one unit of rapid acting insulin willmetabolize 12-15 grams of carbohydrates. The application also assumesthat one unit of rapid acting insulin is required to lower blood glucoseby 50 mg/dl.

Once the dose is determined, the injection device 256 may inject thedetermined dose. As discussed below with reference to FIG. 3A, the usercan prime the insulin cartridge by selecting the “prime” screen from theuser interface of the injection device 256. Pressing the enter button302 and then selecting the prime function followed by pressing theinject/prime button 301 causes the injection device 256 to extend aplunger into a medicament cartridge, causing the medicament cartridge toexpel fluid from a needle. The plunger may be stopped manually when theprime button 301 is released (such as when the patient observes fluidexiting the needle). In another embodiment, the auto-prime function canbe used in which a fixed volume of fluid, e.g., 3 units (or 30microliters), is expelled.

FIG. 2B illustrates another exemplary screenshot 280 of a smart phoneapplication running on a smart phone in accordance with an exemplaryembodiment of the invention. Screenshot 280 illustrates a blood glucosehistory 282 generated from data received from the CGM 254. CGM data ispreferably transmitted from the CGM 254 to the smart phone applicationevery 10 seconds. In some embodiments, the CGM 254 is in continuous,near continuous, or regular communication with the smart phoneapplication. Target high and low blood glucose levels are preferablyhighlighted in the blood glucose history 282. The appropriate bolusdosage is determined based on prior user information including bodyweight, target glucose, insulin-to-carbohydrate ratio, and the mostrecent blood glucose value received from CGM 254. The determined dose isdisplayed in the determined dose field 284 of the user interface. Toinitiate a dose as determined, the user selects the “accept” button 286on the smart phone user interface. The user interface also preferablyincludes “up” and “down” arrow buttons to adjust the dose as needed. The“send dose” button 288 causes the smart phone application to transmitthe dose information to the injection device 256. The injection device256 includes an “inject” button that, when pressed, initiates injectionof the determined and transmitted dose.

FIG. 2C illustrates exemplary screenshots of a smart pen applicationrunning on a smart phone in accordance with an exemplary embodiment ofthe invention. Screenshot 360 illustrates a blood glucose history 382generated from data received from the CGM 254. CGM data is preferablytransmitted from the CGM 254 to the smart phone application as specifiedabove. A plot of blood glucose history 382 generated from data receivedfrom the CGM 254 shows blood glucose level trends. To help the patientfurther, other clinically relevant information such as a most recentblood glucose data 384 that was transmitted from CGM 254 and used fordose determination and also a most recent insulin dose injection 386 areshown. Data for the most recent insulin dose injection 386 can bereceived from the injection device 256. In some embodiments, theinjection device 256 is in continuous, near continuous, or regularcommunication with the smart phone application. Exercise goal andcurrent progress data is displayed in field 390. Exercise data may bereceived from a physical activity monitoring device or application.Other relevant information such as Carbs consumption for the day isdisplayed in field 388. Carbs consumption can be based on dietinformation received from a diet monitoring device or application.

Screenshot 361 illustrates an adjustment screen. A current glucose 362is shown. A target blood glucose 364 is also shown, and preferablyhighlighted in the glucose history 382 of screen 360. A determined bolusdosage 366 is determined based on prior user information includingtarget glucose and the most recent blood glucose value received from CGM254. The determined dose is displayed in the determined dose field 366of the user interface. To finalize the injection, the user interface ispreferably used to adjust the dose based on the Carbs 368 as needed. Thefinal determined dose 370 is used by the injection device 256 to performthe injection. The injection device 256 includes a button or triggerthat, when engaged, initiates injection of the determined dose.

In an alternative embodiment, the smart phone application featuresdescribed in reference to FIGS. 2A-C may instead be integrated into theuser interface of the injection device 256. Data may be received,continuously, near continuously, regularly, or intermittently, from oneor more external devices or via a user interface of the injection device256.

FIG. 3 is a block diagram of the smart pen injection device 256described above. The injection device 256 includes a controller 320 forcontrolling a motor 322 and a display 306. The injection device 256further includes a memory 324 for storing program instructions as wellas data. The injection device 256 is configured to continuously, or nearcontinuously, communicate with one or more external devices, such as forexample, a continuous glucose monitor, a computing device, an exercisemonitoring device, a sleep monitoring device, a diet monitoring device,and a scale. The injection device 256 preferably includes a wirelesstransceiver 326 and internal antenna 328 for communicating with otherdevices wirelessly. The injection device 256 can also include a wiredcommunication interface.

The injection device 256 further includes a motor 322, a shaft 332, aplunger 313, an insulin cartridge 308, and a pen needle 309. In responseto receiving instructions to perform an injection, the controller 320activates the motor 322. The motor 322 is engaged to the shaft 332. Whenactivated, the motor 322 can cause the displacement of the shaft 332.The shaft 332 is engaged to the plunger 313. The insulin cartridge 308is sealed at a proximal end of the cartridge by the plunger 313, whichis adapted to slide within the cartridge 308 and change the volume ofthe cartridge 308 in response to displacement of the shaft 322. The penneedle 309 is engaged to the distal end of the cartridge to dispensemedicament as the volume of the cartridge is reduced by plunger movementof plunger 313. In some embodiments, controller is configured to set amedicament delivery amount by setting a displacement distance of themovable plunger 313. An encoder 330 is preferably connected to the shaft332 of the motor 322, and provides encoder signals corresponding tomotor movement to the controller 320. The encoder 330 can include asensor adapted to sense movement of the encoder 330 and to providesignals indicative of encoder movement to the controller 320.Accordingly, the encoder signals received by the controller 320 from theencoder 332 are indicative of movement of a plunger 313 within amedicament cartridge 308. The controller 320 can be configured tocontrol the medicament delivery amount based on the signals receivedfrom the encoder 330. In some embodiments, the motor 322 is adapted todisplace the plunger for the duration of a control signal.

FIGS. 3A-3D illustrate an exemplary embodiment of a smart pen injectiondevice 256. FIG. 3A depicts a perspective view of the injection device256. The injection device 256 includes a main housing 300, userinterface buttons 301-304, a display 306, an insulin cartridge 308, apen needle 309 and a cap 310. The user interface buttons 301-304 and thedisplay 306 are positioned on the surface of the main housing 300. Theinsulin cartridge 308 protrudes out from and is engaged to one end ofthe main housing 300. The pen needle 309 protrudes out from and isengaged to the end of the insulin cartridge 308 opposite the mainhousing 300. The cap 310 is configured to fit over the insulin cartridge308 and the pen needle 309. The cap 310 is further to engage with andremovable secure to the main housing 300. The user interface button 301can be configured to cause an injection upon engagement. The userinterface buttons 303 and 304 can be configured to select between one ormore options displayed on the display 306. The user interface button 302can be configured to cause the display 306 to revert to a previousconfiguration.

FIG. 3B shows a cross sectional view of the injection device 256. Insidethe housing 300 resides electronics, including the motor 312, theplunger 313, and a gear 314. In some embodiments, the motor 322 cancause movement of the gear 314. In response, the gear 314 can cause thedisplacement of the plunger 313 along a primary axis of the insulincartridge 308.

FIGS. 3C and 3D depict a top exploded view and a bottom exploded view,respectively, of the injection device 256. Inside the housing 300further reside one or more batteries 311. The housing 300 furtherincludes a battery compartment cap 307 which is removably secured to thehousing 300. The battery compartment cap 307 can be removed from thehousing 300 to allow for access to the batteries 311.

A preferred embodiment of the invention is battery powered, preferablyat 3 VDC. The device is preferably equipped with a 12 mm gear motor, ata 100:1 gear ratio to drive a 2-56 threads per inch lead screw togenerate injection force against a pusher bar with anti-rotation to pusha plunger against the cartridge stopper. The gear motor designincorporates a rotary optical encoder with a photo-interrupter sensor toaccurately control the plunger speed. The system also provides a highlyaccurate position sensing, index/end-of-travel and safety interlock. Thespecified motor drive system preferably generates about 30 psi pressurewith standard 29, 30 and 31 gauge needles at approximately 3 pound forceload, and up to 160 psi under occlusion. The 30 psi exceeds the pressurerequirements for subcutaneous injection. The 160 psi meets the pressurerequirements for intradermal injection. The delivery accuracy of thesystem using a 3 ml insulin cartridge (with no load) is equivalent todelivering 30 units of insulin in 5 seconds.

FIG. 3E illustrates an exemplary user interface flow diagram, whereineach box represents screens presented on the device. The user interfacecan include a “home screen”, from which one or more other displayscreens can be selected. The user interface can also include a “doseentry” screen which allows for the receipt, entry, and display of doseinformation. The dose entry screen may also include a “doseconfirmation” field. The dose confirmation field may include an“injection progress” field, a “success” status field, and a “cancelled”status field. The user interface may further include a “dose history”screen, which can include information related to previous injectionevents. The dose history screen can include a “review” field and a“clear history” field, allowing for the deletion of informationregarding previous injection events. The user interface may furtherinclude a “change cartridge” screen, which includes information relatedto the status of the insulin cartridge 308 within the injection device256. The change cartridge screen may include a “remove old” field whichcan indicate that the insulin cartridge 308 is in a condition forremoval from the injection device 256, a “replace” field which canindicate that the insulin cartridge 308 is in a condition forreplacement, and a “prime” field which can indicate that the insulincartridge 308 is in a condition for priming. The user interface may alsoinclude a “prime” screen, which allows for entry and display of priminginformation. The prime screen may include a “needle positioning” fieldwhich can include information related to the position of the needle 309,a “press inject button until primed” field which can allow for theselection of a priming option in which the user presses the injectbutton until the injection device 256 is primed, and an “auto prime”field which can allow for the selection of a priming option in which theinjection device 256 is automatically primed. The user interface furtherincludes a “settings” screen, which can allow for the selection of aplurality of settings related to the injection device 256. The settingsscreen includes a “time set” field which can allow for the selection ofa time, a “maximum dose” field which can allow for the selection of amaximum dose, a “speed” field which can allow for the selection of thespeed of the injection device 256, a “power” field which can allow forthe selection of the power of the device 256, a “brightness” field whichcan allow for the selection of the brightness of the display 306, and a“reset” field which can allow for the resetting of one or more settingsto original conditions. The user interface further includes a“warning/errors” screen that can display warning messages to a user. Thewarning/errors screen includes a “temperature out of range” field whichindicates that the temperature of the insulin is outside of a predefinedrange, a “medication expired” field which indicates that the insulin hasexpired, and a “clock not set” field which indicates that a time settinghas not been selected.

FIG. 4 illustrates a system according to an embodiment of the presentinvention for medication adherence and wellness monitoring. A centralfeature of this embodiment is a data hub 400 that wirelesslycommunicates with other components in the system, including a smartinjection device 256, a health management access point 210, a remoteserver 410, a smart phone 420, and receives optional wellness data frompartner companies via component 430. Server 410 is preferably used asaccess to data by insurance companies or other similar third partyentities with authorized access to the data. A BGM 204 or a CGM 206 arepreferably wirelessly connected to smart injection device 256 to provideglucose readings to the injection device 256. In some embodiments, theBGM 204 or the CGM 206 are in continuous, near continuous, or regularcommunication with the injection device 256. Glucose readings, and otherdata as will be discussed further below, are used to determine amedicament dose for the patient 440. Smart injection device 256 sets thedose amount based on the determined medicament dose. The smart injectiondevice 256 self primes the medicament cartridge prior to injection,informs the patient 440 that the dose is ready for injection, and thendispenses the dose when the patient injects the pen needle and presses a“dispense” button on the smart injection device 256. The results of theinjection, including dose amount, time of injection, and whether theinjection was successful, are stored in a memory of the injection device256 and transmitted to the hub 400. The smart injection device 256 maybe in continuous, near continuous, or regular communication with the hub400. The injection device 256 may communicate with one or more devicesthrough suitable communication technology including a cellular network,a wireless network, such as Wifi, Bluetooth, and Zigbee, or a wirednetwork. From the data hub 400, historical data including glucosereadings and injection data may be transmitted to health managementaccess point 210 and/or remote server 410.

The hub 400 may also receive data from the smartphone 420, which caninclude inputs and instructions from a user. The component 430 caninclude one or more devices for monitoring wellness data, which caninclude data related to exercise, diet, sleep, weight, and othermedicines used by the patient. The wellness data can be transmitted tothe hub 400 where it can be used for determining a medicament dose atthe hub 400 or transmitted to the injection device 256 for determinationof a medicament dose.

Some injection related data may be transmitted from the hub 400 to thehealth management access point 210, from which the data can be accessedby one or more third parties, such as for example, a family member ofthe patient, a physician, a caregiver, or a pharmacy. The healthmanagement access point 210 may further allow for the input of data byone or more of the physician, caregiver, or pharmacy, which can betransmitted to the hub 400 and used in determining a medicament dose.

In one embodiment, an exemplary smart bolus injector enhances theattributes of BD's Glucose Binding Protein-Based Continuous GlucoseMonitoring (GBP CGM) by integrating the bolus injector with a GBP CGM,the delivery system advantageously provides a less invasive alternativeas compared to a conventional insulin infusion pump combined with aGlucose Oxidase based CGM or a conventional smart pen used together withepisodic capillary blood glucose self-monitoring (BGM). Glucose BindingProtein and continuous glucose monitoring is described in ContinuousGlucose Monitoring Using a Novel Glucose/Galactose Binding Protein:Results of a 12-Hour Feasibility Study with the Becton DickinsonGlucose/Galactose Binding Protein Sensor; Kevin Judge, M. D., LindaMorrow, M. D., Alexander G. Lastovich, M. Eng., David Kurisko, M. B. A.,Steven C. Keith, M. S., Jacob Hartsell, M. S., Bruce Roberts, ElaineMcVey, MStat, Kristin Weidemaier, Ph.D., Khin Win, M. D., and MarcusHompesch, M. D., as well as U.S. Pat. No. 6,855,556, issued Feb. 15,2005, U.S. Pat. No. 7,851,593, issued Dec. 14, 2010, U.S. Pat. No.7,496,392, issued Feb. 24, 2009, U.S. Pat. No. 7,787,923, issued Aug.31, 2010, U.S. Pat. No. 7,792,561, issued Sep. 7, 2010, and U.S. Pat.No. 8,623,639, issued Jan. 7, 2014, the entire contents of each of whichare hereby incorporated by reference.

One embodiment provides the means to improve upon the performance ofstandard pen or syringe injector devices by taking advantage of CGMattributes. CGM advantageously helps patients become more aware of theirglucose levels and how they can change based on food, exercise,medication, or other activities. Using a CGM monitor together with anexemplary bolus injector system as described herein allows patients tofeel more confident about the way they are managing their diabetes, andcan subsequently improve outcomes and help lower their HbA1c (glycatedhemoglobin) levels.

One advantage of an exemplary smart bolus injector integrated with a CGMis to help diabetic patients achieve their therapeutic goal to lowertheir HbA1c level. To prevent extreme glucose fluctuations, most insulinusers check their blood sugar 2-6 times per day, depending on theirtherapy regimen. For standard Pen/BGM users, this will require use oftwo separate devices with multiple steps and multiple needle sticks foreach. Exemplary embodiments of the invention preferably andadvantageously combine the functions of an insulin pen, pen needle, andCGM monitoring into a single less invasive device that obtains thepatient's glucose reading as well as delivering their insulin with fewerneedle sticks. This provides a more convenient solution and encouragesgreater glucose testing frequency and provides patients and theirhealthcare providers with the blood glucose data to make better dosingdecisions.

It should be understood that the smart bolus injector described abovemay be used within an artificial pancreas system. The bolus calculatorneed not be separate, but may be tied into a continuous glucoseprocessing control system. The benefit for such a system is that thebolus can be better determined within the context of continuing basaldeterminations to improve medication outcomes and quality of care.

An exemplary embodiment of the invention includes a safety feature toshutoff the delivery system when hypoglycemia (low blood sugar) isdetected. This feature responds to low blood glucose readings from theglucose sensor by stopping the bolus injector from delivering insulin.For patients who are experiencing low blood glucose, the system willalso preferably provide personalized instructions on how to obtain andreceive a glucagon (GLP-1) injection or any other personalized measure.

An exemplary embodiment of the invention may be used by people who areusing an insulin pump with CGM but who want to use a less restrictiveand simpler insulin delivery system such as a bolus injector wirelesslyconnected to a CGM, either permanently or on a temporary basis.

Another advantage of an exemplary embodiment of the invention is thatthe smart bolus injector may be also used together with an insulininfusion pump to prolong the life of the pump reservoir, or to allow theuse of a pump with less driving power or less pressure. The smart bolusinjector can be configured to wirelessly communicate with the insulininfusion pump. In some embodiments, the smart bolus injector and insulininfusion pump are in continuous, near continuous, or regularcommunication.

Preferably, embodiments of the invention have a manual feature thatpermit the smart bolus injector to function like a conventional penneedle in case of an emergency or other malfunction of other componentsof the overall system.

Another advantage of exemplary embodiments of the present invention ishigh pressure delivery of medicament. The exemplary bolus injectorsystem improves upon the performance of standard pen and syringeinjector devices and/or insulin pumps, or any other similar devices witha primary reservoir or cartridge, by providing the specific needledelivery forces required to facilitate user/patient delivery ofmedicaments with high viscosity or of medicaments with standardviscosity into the dense intradermal space where the force requirementmay be higher.

A preferred embodiment of the present invention preferably providestactile and visual feedback to the user. The visual feedback may bemonitored on the injector display screen. However, other embodiments mayonly provide one of tactile or visual feedback, or other types offeedback alone or combined, such as auditory feedback. Other embodimentsmay not provide feedback to the user.

Wearing a pump can be inconvenient for patients. This is particularlytrue for active patients, for patients at the beach or asleep. Generallyit is inconvenient for users to be connected to a conventional insulinpump. By switching to an exemplary bolus injector system according to anembodiment of the invention a patient can disconnect from the pump forshort periods or even permanently.

Embodiments of the present invention also minimize the risk of infectionassociated with conventional insulin pump systems. If patients fail tochange the insertion site of the cannula of a conventional insulin pumpevery two or three days the risk of infection increases. Embodiments ofthe present invention more closely resemble simpler injection systemswith the accompanying reduced risk of infection associated with acannula that remains in the patient's skin for several days.

Embodiments of the present invention provide a near closed loopinjection system that controls the volume of liquid medicamentintroduced into the body of a user. For a conventional insulin infusionpump, the infusion rate of the fluid is controlled. A closed loop systemincludes a sensor system such as a CGM and a delivery system. Inembodiments of the invention the sensor signal is used to generate acontroller input to operate the delivery system. Embodiments of thepresent invention preferably deliver liquid into the user at fixedvolumes, rather than a rate. The volume is set by commands from acontroller. In a diabetes application, the sensor system monitors theglucose concentration in the body of the user, and the liquid introducedby the delivery system into the body of the user includes insulin. Thesensor system uses the sensor signal to generate a message that is sentto the delivery system. The message includes the information used togenerate the controller input. The sensor may be a subcutaneous sensorsuch as a GBP CGM in contact with interstitial fluid. Controlling thefluid delivery by bolus volume, as compared to infusion rate,significantly shortens the time scale for delivery and is moreconvenient for the patient.

Embodiments of the present invention advantageously perform insulin pumpfunctions with high accuracy but without the burden of being directlyattached to the patient's body like a conventional insulin pump. Forsimplicity and convenience, the system is preferably designed to includeautomation and form factors in order to reduce the hassle of reservoirchange and priming to make it more intuitive and user friendly.Furthermore, for ease of use and ease of commercialization, a bolus autoinjection system according to an embodiment of the invention may beconstructed using standard pen injector parts such as commerciallyavailable prefilled insulin cartridges and pen needles. For example, thedevice may employ a 300 unit insulin supply and a 5 mm long 31G BD penneedle. The system is preferably reusable to keep the cost per injectionto a minimum, and to increase the likelihood of patient adoption andaffordability. Furthermore, as component costs for the system come down,a smart bolus system could be embodied in prefilled disposable pens.

Embodiments of the present invention continuously monitor glucose levelseither by communicating with a separate CGM component, or byincorporating a blood glucose monitoring component. The devicepreferably prepares the device with the required insulin dose for apre-scheduled and/or an on-demand insulin injection. It should beunderstood that the device may be integrated with any glucose monitoringsystem including a GBP CGM, a Glucose Oxidase based CGM, or an episodiccapillary blood glucose self-monitoring (BGM).

Another exemplary embodiment of a system according to the invention isdescribed in connection with FIG. 5. This system 500 preferably includesan insulin Smart Pen 502, an integrated (embedded) BGM sensor 504, a BGMTest Strip 506, and a display 508. In a single device format, aminiaturized digital low cost BGM sensor 504 is incorporated into thepen hardware. The BGM sensor 504 measures a patient's blood glucose fromthe test strip 506 and then preferably displays the measured bloodglucose results on the smart pen display 508. A preferred embodiment ofthe invention measures a patient's blood glucose first and thendetermines an insulin dose and delivers the needed insulin in a singleintegrated device.

A preferred embodiment of the invention is to perform blood glucosemeasuring, insulin injection in connection with a patient maintainingjournal records all in the same device. This embodiment advantageouslycombines the features of several devices into one single device and,thereby for simplicity and convenience, replaces multiple devices intoone self-care device.

An exemplary system 600 that is bolus injector centric will now bedescribed in connection with FIG. 6. This embodiment reliessignificantly on a handheld model of a smart bolus device. The smartbolus device 602 preferably includes a large display screen 604 such asan OLED screen to provide injection information. The smart bolus device602 also includes communication components to perform data transfer.Data transfer is preferably to or from the cloud, and may beaccomplished by any suitable means including a cellular network, awireless network, such as Wifi, Bluetooth, Zigbee, or a wired network.In this embodiment the communications components are contained in thedevice so that a user does not require a separate device such as a smartphone 606. However, this embodiment may still permit the use of a smartphone 606 in conjunction with the smart bolus device 602 for thetransmission of some data, such as for example to acquire simplereminders and transmit emergency data. As used herein, the term “smartphone” refers to mobile devices with modern processors, communicationscomponents, and user interfaces, and includes the ability to runcustomized programs or “apps”. If glucose monitoring functions are notbuild into the smart bolus injector, then the device further includescommunications components to communicate with a separate glucosemonitoring device, such as a CGM device 608 or a BGM (not shown). TheCGM 608 or BGM may be hardwired or wirelessly connected to the smartbolus device 602.

In accordance with an illustrative embodiment, the smart bolus device602 is in continuous, near continuous, or regular communication with oneor more external devices such as the smart phone 606, the CGM device608, or the BGM. The device is programmed to determine an insulin dosebased on patient information, and to facilitate auto-dosing. Auto-dosingincludes priming, performing a bolus injection, data recording andtransmission to a secure site for data management. The patientinformation can include exercise information, sleep information, dietinformation, weight information, and other medicines used information.The data recorded preferably includes both glucose concentration dataand insulin injection data performed by the bolus injector. An OrganicLight-Emitting Diode (OLED) display is preferred due to the ability topresent clear images and text lines without a backlight, and to scrollin the horizontal and vertical directions. A scrolling display ispreferred to improve user navigation through the menu to customize dataand to determine an insulin dose prior to injection. The scrollingdisplay also is preferred for transferring post injection data. OLEDdisplays are preferable in systems for diabetes patients and otherpatients who may have difficulty with vision.

The system 600 of FIG. 6 is smart bolus device 602 centric where the penis equipped with smart functions to communicate with other devices,determine and prepare injection dose and subsequently sends the info toa secure cloud 610. Smart phone 606 is only needed for reminders andother simple communication tasks. The system 600 is preferable forpatients who prefer to minimize dependence on a smart phone.

An exemplary system 700 that is smart phone centric will now bedescribed in connection with FIG. 7. In this embodiment the primaryfunction of the bolus device 702 is to facilitate proper insulininjection. The bolus device 702 offers basic safety and smart injectionfunctions. The features to perform the increasingly complexdeterminations and means to interact with patients, healthcare providersand payers are located on a mobile device such as a smart phone 706 andin the cloud 710. Smart phones have the ability to receive glucosereadings from a CGM 708 or a BGM (not shown). The CGM 708 or BGM may behardwired or wirelessly connected to a smart phone. In some embodiments,the smart phone is in continuous, near continuous, or regularcommunication with the CGM 708 or BGM. The smart phone 706 determinesthe required insulin dose based on patient information and feedback, andthen transmits the data to the bolus device 702 in order to program aninjection.

The smartphone 706 may be in continuous, near continuous, or regularcommunication with the bolus device 702. After receiving the determinedinsulin dose information from the smart phone 706, the bolus device 702prepares the device for injection followed by helping the user toperform self-injection that preferably entails both priming and bolusinjection. The bolus device 702 also preferably transfers the successfulinsulin dose injection data along with a time stamp back to the smartphone 706. The smart phone 706 in turn relays the data to a secure cloudsite 710 for data management and access by the patient, their healthcareprovider, or any other interested and authorized party. This embodimentmay be less expensive and easier to adopt by patients who already carrya smart phone since some of the components, including memory, processor,communications, and application layer, need not be built into the bolusinjector device.

The system 700 is smart phone centric where substantially all of thecommunication apps and patient processes are located. Smart phone 706communicates with the CGM 708 and receives the blood glucose data. Basedon that information, smart phone 706 determines the required insulindose and sends it to the bolus device 702. The smart phone 706 may alsoreceive information related to exercise, diet, sleep, weight, and othermedicines taken through an input from the user or from one or moredevices or applications. The required insulin dose information can bebased in part on the exercise, diet, sleep, weight, and medicationinformation. Bolus device 702 prepares the injection device with thedetermined dose for auto dosing by the patient. Bolus device 702 alsocommunicates the injection data (such as successful or incompleteinjection) back to the smart phone 706. The smart phone 706 will sendthe info to the cloud server 710 where it can be accessed by multiplestake holders (patient, relatives, health care provider, insurance, andso on).

One embodiment integrates with a Glucose Binding Protein-BasedContinuous Glucose Monitoring (GBP CGM) to provide a less invasivealternative as compared to an insulin pump combined with a GlucoseOxidase based CGM or a smart pen used together with an episodiccapillary blood glucose monitor (BGM).

Embodiments of the present invention are advantageous for patients whoare on a premixed formulation of short acting and long acting insulin tocontrol their diabetes. Roughly 30% of patients in the U.S. and over 70%of patients in China currently use premixed insulin that is acombination of short and long acting. One difficulty with premixedformulations of insulin is that the patient is required to mix theinsulin properly prior to each injection. By integrating the premixinsulin injection with an enhanced monitoring and improved deliverymethod, the smart bolus delivery system could improve therapeuticefficacy, reduce the risk of hypoglycemia, and improve patient treatmentoutcome.

An embodiment of invention smart injection device preferably includestwo features. The first is electronics and connectivity to acquireglucose data, either by a wireless or wired connection, from designatedsources including monitoring devices. The designated sources can includeCGM's, BGM's, or smart phones. The designated sources may also includedevices for monitoring exercise, sleep, diet, weight, and othermedication used. In some embodiments, the smart injection device is incontinuous, near continuous, or regular communication with one or moreof the designated sources. The second feature is automation technologyto (a) determine an insulin dose amount by using a bolus calculator, orreceive a determined insulin dose from another source, such as a smartphone, (b) mechanical and electronic mechanisms to prepare the device toperform an auto injection, and (c) electronics and connectivity tocommunicate time-stamped data, including glucose concentration andinsulin injection information to a secure database management systemwhere various groups of stakeholders such as patients, healthcareproviders and payers may have access to the data.

The cornerstone of good diabetes management is education thatfacilitates changes in behavior to help improve glucose control andother health outcomes. Unfortunately, many patients often receiveminimal instructional information, if any at all, about how to managetheir diabetes. Patients need ongoing reinforcement of key concepts andbehaviors. Without this ongoing reinforcement, therapy adherence hasbeen shown to decline, healthy living behaviors cease, and complicationsincrease, leading to expensive care and interventions. In order toimprove patient education regarding diabetes management, an exemplaryembodiment of the present invention preferably includes a number ofadditional features that will now be described.

First, the system covers key elements of good diabetes management andcomplication prevention. The focus is on reinforcing education aroundinjection technique current, future infusion sites, and glucose controlto lower A1c. More specifically, the system shows patient how to acquirephysiological data, determines insulin dose requirements, sets the bolusinjector to deliver a dose by priming and delivering a bolus injection,and records data related to glucose concentration measured by theglucose monitor and insulin injected by the bolus injector.

Second, the system helps diabetics to identify and analyze trends on howtheir blood glucose reacts to their therapy. The system enables patientsto communicate therapy doses to other devices, and to capture data froma CGM/BGM and insulin delivery devices. The system preferably providesfor overall data management for use by the patient, their healthcareprovider and other interested and authorized parties.

Third, the system provides a manual mode for when the smart features ofthe system are non-functional. If the system integrates with a smartphone, then the system preferably provides behavior reinforcement viathe smart phone for patients and healthcare providers on how to handlean emergency situation when the smart delivery system is not functionaland needs to go to the manual mode.

Fourth, the mobile education method of embodiments of the presentinvention ensures that the information is current, timely andcustomizable.

Fifth, the number of diabetes drugs, both oral and injectable, isexpanding along with new drugs and new formulations of existing drugs.This may lead to potential confusion and safety risks. Insurers andhealthcare providers are increasingly interested in gaining a betterunderstanding of patient drug behavior, including adherence, compliance,and so on. The present embodiment provides a way to help diabeticscapture, store, and report information about drug use, includingidentifying which drug is being used, how much drug is being infused,when the drug is being infused, and other relevant factors. Thisinformation may be used by the patient to ensure proper use and safety.Moreover, the information may form part of a care information ecosystemfeeding processes and reporting systems.

Sixth, for patients with type 2 diabetes who are using insulin withother medicaments, the smart delivery system has the capability to sendmultiple daily messages to facilitate diabetes management. For example,patients with insulin resistance using Byetta via a pre-filled peninjector may be instructed to take their injections twice daily, and totake an Actose medication pill at the appropriate times. This regimenused together with proper diet and exercise helps control blood sugar inadults. Accordingly, the smart phone application portion of the systemcan provide necessary alerts to the user to improve their compliancewith their healthcare providers designated regimen.

Systems according to an exemplary embodiment of the inventionadvantageously have the delivery accuracy above 97% when performed inopen air of highly expensive insulin infusion pumps with the low costassociate with small battery powered 12 mm gear motors used with opticalencoders. In addition, systems according to an exemplary embodiment ofthe invention advantageously generate over 160 psi pressure to meet therequirements of intradermal injection.

While certain exemplary embodiments of the present invention have beenshown and described herein with reference to certain preferredembodiments thereof, it will be understood by those skilled in the artthat various changes in form and details may be made therein withoutdeparting from the spirit and scope of the invention.

What is claimed is:
 1. An electronic insulin delivery device foradministering a bolus of insulin to a patient, comprising: a receiverconfigured to receive patient glucose information from an electronicglucose monitor; a processor configured to read the received patientglucose information and determine an appropriate insulin bolus dose forthe patient; a dose setting mechanism configured to set an insulindelivery amount corresponding to the determined insulin bolus dose; anda housing having at least one user interface button corresponding to adispense function for dispensing the determined insulin bolus dose. 2.The device of claim 1, wherein the receiver is configured to receivedata from a physical activity monitor, a sleep monitor, or a scale. 3.The device of claim 1, wherein the insulin delivery device furthercomprises an insulin cartridge and a pen needle at a distal end of thecartridge.
 4. The device of claim 1, wherein the dispense functioncomprises a motor connected to a displacement gear.
 5. The device ofclaim 4, wherein the insulin delivery device further comprises anencoder in connection with the motor, and a sensor adapted to sensemovement of the encoder and to provide signals indicative of encodermovement to a controller of the insulin delivery device, wherein saidcontroller is adapted to control the insulin delivery amount based onthe signals received from the encoder.
 6. The device of claim 4, whereinthe motor is adapted to prime the cartridge and pen needle prior toinsulin delivery.
 7. The device of claim 1, further comprising a memoryfor storing the received glucose information from the glucose monitor.8. The device of claim 7, wherein the processor is programmed to readthe glucose information from the memory to determine insulin deliveryinformation comprising delivery success status, dose amount, and time ofinsulin delivery.
 9. The device of claim 1, wherein the glucoseinformation comprises most recent glucose levels and historical glucosetrend information.
 10. The device of claim 1, wherein the appropriateinsulin bolus dose is determined based on at least a most recent glucosereading, patient weight, an insulin-to-carbohydrate ratio of thepatient, and an exercise factor of the patient.
 11. A method in anelectronic insulin delivery device for administering insulin to apatient, comprising: receiving glucose information from a glucosemonitor; receiving additional patient information from an electronicdevice via a wireless communication interface; setting an insulin bolusdosage amount based on the glucose information and the additionalpatient information; and activating a user interface on the electronicinsulin delivery device to display the insulin bolus dosage amount. 12.The method of claim 11, further comprising receiving an input on a userinterface of the insulin delivery device.
 13. The method of claim 11,wherein receiving additional patient information comprises receivingdata from a physical activity monitor, a sleep monitor, or a scale. 14.The method of claim 11, wherein the insulin delivery device comprises aninsulin cartridge and a pen needle at a distal end of the cartridge. 15.The method of claim 11, wherein the insulin delivery device furthercomprises a motor connected to a displacement gear.
 16. The method ofclaim 15, further comprising: sensing movement of an encoder inconnection with the motor; providing signals indicative of encodermovement to a controller of the insulin delivery device; and adjustingthe insulin bolus dosage amount setting based on the signals received bythe controller.
 17. The method of claim 15, further comprising settingan insulin priming amount, wherein the motor is adapted to prime theinsulin cartridge and pen needle prior to insulin delivery.
 18. Themethod of claim 11, further comprising storing in a memory the receivedglucose information from the glucose monitor.
 19. The method of claim18, further comprising reading the glucose information from the memoryand determining insulin delivery information comprising delivery successstatus, does amount, and time of insulin delivery.
 20. The method ofclaim 11, wherein the glucose information comprises the most recentglucose level and historical glucose trend information.
 21. The methodof claim 11, wherein determining an insulin bolus dose amount is basedon at least a most recent glucose reading, patient weight, aninsulin-to-carbohydrate ratio of the patient, and an exercise factor ofthe patient.
 22. An electronic insulin delivery device for administeringa bolus of insulin to a patient, comprising: a receiver wirelesslyconfigured to wirelessly connect to an electronic glucose monitor and anelectronic device, the receiver configured to receive patient glucoseinformation from the electronic glucose monitor and additional patientinformation from the electronic device; and a processor configured to:read the received patient glucose information and the additional patientinformation; determine a patient status based on the received patientglucose information and additional patient information; determine if anotification should be actuated; and actuate a notification.
 23. Thedevice of claim 22, further comprising a housing having a user interfaceconfigured to display a notification.
 24. The device of claim 22,wherein the electronic device comprises a physical activity monitor, asleep monitor, or a scale.
 25. The device of claim 22, wherein theelectronic insulin delivery device is further configured to indicate anotification through auditory, visual, or tactile feedback.
 26. Thedevice of claim 22, further comprising a memory for storing the receivedglucose information and received additional patient information, whereinthe processor is configured to read the glucose information andadditional patient information from the memory to determine the patientstatus.
 27. The device of claim 22, further comprising a transmitterconfigured to transmit a notification to an external device.
 28. Thedevice of claim 22, wherein the processor is further configured todetermine an appropriate insulin bolus dose for the patient, based onthe received patient glucose information and the received additionalpatient information.
 29. The device of claim 28, further comprising adose setting mechanism configured to set an insulin delivery amountcorresponding to the determined insulin bolus dose.
 30. The device ofclaim 29, wherein the appropriate insulin bolus dose is determined basedon at least a most recent glucose reading, patient weight, aninsulin-to-carbohydrate ratio of the patient, and an exercise factor ofthe patient.